NEW YORK — Allergan, the maker of the Botox wrinkle treatment, challenged the government’s ban on off-label drug marketing to doctors, saying it violates the company’s right to freedom of speech.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses.

Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

While physicians can legally prescribe a drug for unapproved uses, companies are forbidden from marketing the product, especially to physicians, for any use not sanctioned by the FDA.

The FDA said it doesn’t comment on pending litigation. The lawsuit was filed in U.S. District Court for the District of Columbia against the U.S. government and the FDA.

The catalyst for the lawsuit is a requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment.

“Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment,” Allergan spokeswoman Caroline Van Hove said in a statement.

Drug developers often walk a tight line with off-label drug practices and getting caught on the wrong side can be expensive. New York-based Pfizer Inc. paid a $2.3 billion settlement last month over allegations it marketed drugs for off-label use.

Part of the logic behind the FDA rule is this: The agency has reviewed detailed clinical trial data, spanning years, before approving a drug’s use for a specific purpose. That same level of scientific, controlled review has not gone into unapproved uses.

In a statement Thursday, Allergan said some of Botox’s off-label uses are medically accepted and commonly prescribed.

“Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses,” the company said, estimating that about 20 percent of Botox use is off-label.
The ban on off-label marketing to doctors is particularly difficult for Allergan, the company said, since the FDA has required safety updates to Botox’s label.

In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

In general, the new labeling urges physicians to tell patients about the risks of botulin-based drugs and to seek medical care if they develop any symptoms.

“To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique,” the company said. “Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution.”

The Irvine company stressed that the lawsuit doesn’t challenge the government’s ability to prohibit pharmaceutical companies from lying or distributing misleading information. Rather, the company said, it seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox.

Allergan is represented in its lawsuit by Paul D. Clement, a partner at King & Spalding in Washington, D.C., and formerly the Solicitor General of the United States.

Source: http://www.dailynews.com/ci_13471325

The injections are used to get rid of wrinkles by partially freezing muscles.

But scientists have now discovered that they can also stop people being able to express their feelings visually.

That could lead to them keeping their emotions bottled up inside and they could end up perceiving the world in a negative way, researchers said.

Dr Judith Grub, who led the research into the injections in Holland, told The Sun: “Suppressing negative emotions is something we do every day to be polite.

“However, my research shows that paralysing muscles that help you to express emotion leads to internalising these feelings.”

In the study 30 people were shown a series of gruesome images.

Some were allowed to show their emotions while others were asked to keep a blank face as they looked at them.

Those who did not show their feelings perceived the world as a worse place, and felt negative emotions for longer.

Dr Grub added: “Many people think ‘Oh, it’s just Botox - I can get it in my lunch break.’ But they forget that there may be side-effects.”

But British cosmetic treatment expert Dr Patrick Bowler said: “Botox shouldn’t paralyse the face and you should still be able to make facial expressions.”

Is Botox Safe?
Botox and Botox Cosmetic are FDA-approved drugs. Both are a naturally-derived protein called botulinum toxin. Toxins are naturally occurring substances that at defined doses are capable of causing illness. When injected properly with appropriate dosing, the risk of Botox complications is extremely low. However, as with any medical treatment, there is potential for adverse effects, and therefore, prior to treatment patients must be informed about the potential risks of these treatments.

Botox vs. Botox Cosmetic

Botox is a botulinum type A that has been reviewed by the FDA and approved to treat specific medical disorders such as cervical dystonia, strabismus and cerebral palsy. Botox Cosmetic is a botulinum type A that has been reviewed by the FDA and approved to treat frown lines; it is also used off-label to treat other cosmetic indications.

Botox used to reduce wrinkles is a sterile and purified version of the Botulinum Toxin A. When the toxin is injected into the muscle, it works to block the nerve impulses, temporarily paralyzing the muscles that cause wrinkles, thereby causing them to relax more. The net result is that the process of wrinkle formation is reduced. A smoothing effect is seen almost immediately and it continues to improve over the next few days.

The full effects of Botox injections can be seen in 5-7 days. Results may vary on individuals, depending on the severity of wrinkles and the strength of muscles treated. The results last from three to six months after which most patients gradually return to their former state. Normally, Botox Injections should be repeated every 3-4 months. Patients who have had Botox treatments over 12 months may only require further treatments every 6 months.

HOUSTON (AP) - A federal judge in Houston today ordered 27 months in prison for a physician who injected more than 170 patients — with fake botox. Prosecutors say the product used by Doctor Gayle Rothenberg is unsuitable for human use.

HOUSTON — A federal judge sentenced a physician who injected more than 170 patients with a product unsuitable for human use to 27 months in federal prison, U.S. Attorney Don DeGabrielle announced Friday.

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